902 KAR 20:260. Special health clinics.
RELATES TO: KRS 216B.010-216B.131, 216B.990
STATUTORY AUTHORITY: KRS 13A.100, 216B.040, 216B.105
NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.040 and 216B.105 mandate that the Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides minimum licensure requirements for the operation of special health clinics.
Section 1. Definitions. (1) "Governing authority" or "licensee" means the individual, agency, partnership, or corporation, in which the ultimate responsibility and authority for the conduct of the clinic is vested.
(2) "Commission" means the Commission for Health Economics Control in Kentucky.
(3) "License" means an authorization issued by the cabinet for the purpose of operating a special health clinic.
(4) "Certified radiation operator" means a person who has been certified pursuant to KRS 211.870 and 902 KAR 105:010 to 105:070 as an operator of sources of radiation.
(5) "Diagnostic services" means those services which are performed to ascertain and assess an individual's physical health condition.
(6) "Treatment services" means those services provided to an individual who, because of a physical health condition, is in need of medical assistance for the attainment of their maximum level of physical function.
(7) "Qualified registered nurse" means a nurse who is licensed to engage in registered nursing practice pursuant to KRS 314.041.
(8) "Licensure agency" means the Division for Licensing and Regulation in the Office of the Inspector General, Cabinet for Human Resources.
Section 2. Scope of Operations and Services. Special health clinics are institutions which provide limited health services, on an outpatient basis. These services include: family planning clinics, pulmonary care clinics, disability determination clinics, weight loss clinics, speech and hearing clinics, wellness centers, counseling centers, and any clinic which only provides diagnostic services.
Section 3. Administration. (1) Licensee.
(a) The licensee shall be legally responsible for the service and for compliance with federal, state and local laws and regulations pertaining to the operation of the service, limited to the scope of the service's certificate of need.
(b) The licensee shall establish lines of authority and designate an administrator who shall be principally responsible for the daily operation of the clinic
(2) Policies. The clinic shall establish and follow written administrative policies covering all aspects of operation, including:
(a) A description of organizational structure, staffing and allocation of responsibility and accountability;
(b) A description of linkages with inpatient facilities and other providers;
(c) Policies and procedures for the guidance and control of personnel performances;
(d) A written program narrative describing in detail the service(s) offered, methods and protocols for service delivery, qualifications of personnel involved in the delivery of the services, and goals of the service(s);
(e) A description of the administrative and patient care records and reports; and
(f) Procedures to be followed in the event the clinic performs any functions related to the storage, handling and administration of drugs and biologicals.
(a) Medical director. The clinic shall have a medical director who is a licensed physician responsible for all medical aspects of the clinic except those clinics which provide only audiological services.
(b) The clinic shall employ a sufficient number of qualified personnel (e.g., nurses, therapists and technicians) to provide effective patient care and all other related services. There shall be written personnel policies which are made available to all employees.
(c) There shall be a written job description for each position which shall be reviewed and revised as necessary.
(d) Current personnel records shall be maintained for each employee which include the following:
1. Name, address and Social Security number;
2. Evidence of current registration, certification or licensure of personnel;
3. Records of training and experience; and
4. Records of performance evaluation.
(4) In-service training. All personnel shall participate in ongoing in-service training programs relating to their respective job activities including thorough job orientation for new employees.
(5) Medical records.
(a) The clinic shall maintain medical records which contain at least the following:
1. Medical or social history relevant to the services provided, including data obtainable from other providers;
2. Names of referring physician, if any, and physicians orders for special diagnostic services;
3. Description of each medical visit or contact, to include condition or reason necessitating visit or contact, assessment, diagnosis, services provided, medications and treatments prescribed, and disposition made;
4. Reports of all physical examinations, laboratory and other test findings relevant to the services provided; and
5. Documentation of all referrals made, including reason for referral, to whom patient was referred, and any information obtained from referral source.
(b) Confidentiality of all patient records shall be maintained at all times.
(c) Transfer of records. The clinic shall establish systematic procedures to assist in continuity of care where the patient moves to another source of care, and the clinic shall, upon proper release, transfer medical records or an abstract thereof when requested.
(d) Retention of records. After patient's death or discharge the completed medical record shall be placed in an inactive file and retained for five (5) years or in case of a minor, three (3) years after the patient reaches the age of majority under state law, whichever is longer.
(e) Provision shall be made for written designation of a specific location for the storage of medical records in the event the special health clinic ceases to operate because of disaster, or for any other reason. The licensee shall safeguard the record and its content against loss, defacement and tampering.
(f) A specific location shall be designated by the special health clinic for the storage and maintenance of the clinic's medical records.
Section 4. Provision of Services. A licensed special health clinic shall comply with the requirements listed in Sections 3 and 5 of this administrative regulation, the clinic's program narrative, and the additional requirements of this section which relate to the particular service(s) offered by the licensee.
(1) Equipment used for direct patient care by a special health clinic shall comply with the following:
(a) The licensee shall establish and follow a written preventive maintenance program to ensure that equipment shall be operative and properly calibrated;
(b) All personnel engaged in the operation of diagnostic equipment shall have adequate training and be currently licensed, registered or certified in accordance with applicable state statutes and administrative regulations; and
(c) There shall be a written training plan for the adequate training of personnel in the safe and proper usage of the equipment.
(2) Diagnostic services shall be performed in accordance with the special health clinics protocol.
(a) Diagnostic services includes family planning clinics, disability determination clinics, counseling centers, wellness centers and other clinics providing diagnostic services only.
(b) Diagnostic services shall be provided under the supervision of a physician who is qualified by advanced training and experience in the use of the specific technique utilized for diagnostic purposes, except for a family planning clinic, or a wellness center.
(c) The clinic shall prepare a record for each patient to include the date of the procedure, name of the patient, description of the procedures ordered and performed, the referring physician, the name of the person performing the procedure, and the date and name of the physician, if any, to whom the results were sent;
(d) Physical examination services shall be nonabusive and provided in a manner which ensures the greatest amount of safety and security for the patient.
1. Protocols for diagnostic examinations shall be developed by the medical director.
2. Personnel performing physical examination shall have adequate training and be currently licensed, registered or certified in accordance with applicable Kentucky statutes and administrative regulations.
3. Personnel performing physical examinations shall be limited by the relevant scope of practice of state licensure.
4. A wellness center must have at least one (1) person on staff, employed full time, who has current advanced cardiac life support certification.
(3) Treatment services includes pulmonary care clinics, weight loss clinics, and speech and hearing clinics.
(a) Policies. The licensee shall develop patient care policies with the advice of a group of professional personnel that includes one (1) or more physicians and one (1) or more registered nurses. At least one (1) member shall not be a member of the clinic staff. The policies shall include:
1. A description of the services the clinic provides directly and those provided through agreement.
2. Guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, and the maintenance of health records; and
3. Procedures for review and evaluation of the services provided by the clinic at least annually.
(b) Personnel. The clinic shall have a staff that includes at least one (1) physician and at least one (1) licensed nurse. The clinic shall employ such other staff or ancillary personnel that are necessary to provide the services essential to the clinic's operation.
1. The physician shall:
a. Be responsible for all medical aspects of the clinic and shall provide direct medical services in accordance with the Medical Practice Act, KRS Chapter 311. In addition, the physician shall provide medical direction, supervision, and consultation to the staff;
b. In conjunction with the licensed nurse(s) participate in the development, execution and periodic review of the clinic's written policies and services;
c. Periodically review the clinic's patient records, provide medical orders, and provide medical care services to patient of the clinic; and
d. Be present for consultation weekly, and be available within one (1) hour through direct telecommunication for consultation, assistance with medical emergencies, or patient referral.
2. The licensed nurse shall:
a. Participate in the development, execution and periodic review of the written policies governing and the services the clinic provides;
b. Participate with the physician in periodic review of patient health records;
c. Provide services in accordance with clinic policies, established protocols, the Nurse Practice Act (KRS Chapter 314), and with administrative regulations promulgated thereunder;
(i) Arrange for, or refer patients to needed services that cannot be provided at the clinic; and
(ii) Assure that adequate patient health records are maintained and transferred when patients are referred.
(c) The clinic shall carry out, or arrange for an annual evaluation of its total program, shall consider the findings of the evaluation, and take corrective action, if necessary. The evaluation shall include:
1. The utilization of clinic services including at least the number of patients served and the volume of services;
2. A representative sample of both active and closed clinical records; and
3. The clinic's health care policies.
(d) The clinic shall develop and maintain written protocols (i.e., standing orders, rules of practice, and medical directives) which apply to services provided by the center and which explicitly direct the step-by-step collection of subjective and objective data from the patient. The protocols shall further direct data analysis, direct explicit medical action depending upon the data collected, and include rational for each decision made. The protocols shall be signed by the staff physician.
(e) A pulmonary care clinic shall have linkage agreements or arrangements with each of the following:
1. Inpatient hospital care;
2. Physician services in a hospital, patient's home, or long term care facility;
3. Additional and specialized diagnostic and laboratory services that are not available at the clinic;
4. Home health agency;
5. Emergency medical services; and
6. Pharmacy services.
Section 5. Physical environment. (1) Accessibility. The clinic shall meet requirements for making buildings and facilities accessible to and usable by the physically handicapped pursuant to KRS 198B.260 and administrative regulations promulgated thereunder. All clinics shall comply with this requirement by July 1, 1989.
(2) Fire safety. The clinic shall be approved by the Fire Marshal's office before licensure and relicensure is granted by the licensure agency.
(3) Housekeeping and maintenance services.
(a) Housekeeping. The clinic shall maintain a clean and safe facility free of unpleasant odors. Odors shall be eliminated at their source by prompt and thorough cleaning of commodes, urinals, bedpans and other sources.
(b) Maintenance. The premises shall be well kept and in good repair. Requirements shall include:
1. The clinic shall insure that the grounds are well kept and the exterior of the building, including the sidewalks, steps, porches, ramps, and fences are in good repair;
2. The interior of the building including walls, ceilings, floors, windows, window coverings, doors, plumbing and electrical fixtures shall be in good repair. Windows and doors which can be opened for ventilation shall be screened;
3. Garbage and trash shall be stored in areas separate from those used for the preparation and storage of food and shall be removed from the premises regularly. Containers shall be cleaned regularly;
4. A pest control program shall be in operation in the clinic. Pest control services shall be provided by maintenance personnel of the facility or by contract with a pest control company. The compounds shall be stored under lock;
5. Sharp wastes, such as broken glass, scalpel blades, and hypodermic needles, shall be segregated from other wastes and aggregated in rigid disposable containers immediately after use. Needles and syringes shall not be cut, dismantled, or destroyed after use, but shall be placed intact directly into a rigid container. The rigid containers of sharp wastes shall either be incinerated, on site or off site, or disposed of in a sanitary landfill approved pursuant to 401 KAR 47:080; and
6. The clinic shall establish a written policy for the handling and disposal of all infectious, pathological, and contaminated waste if the clinic generates them. Any incinerator used for the disposal of waste shall be in compliance with 401 KAR 59:020 or 401 KAR 61:010.
a. Infectious waste shall be placed in double impervious plastic bags and each bag shall be two (2) mils in thickness. A bag, when full, shall not exceed twenty five (25) pounds. All bags shall be securely closed and a tag, which reads "INFECTIOUS WASTE" and identifies the clinic from which the waste is being removed and shall be attached to the bag in a conspicuous manner.
b. All unpreserved tissue specimens procedures shall be incinerated on or off site.
c. The following wastes shall be sterilized before disposal or be disposed of by incineration if they are combustible:
(i) Dressings and materials from open or contaminated wounds;
(ii) Waste materials and disposable linens from isolation rooms;
(iii) Culture plates;
(iv) Test tubes;
(v) Sputum cups; and
(vi) Contaminated sponges and swabs. (14 Ky.R. 1718; Am. 1923; 2033; eff. 4-14-88; 18 Ky.R. 866; eff. 10-16-91; TAm eff. 12-10-2012.)